Evaluating DNA fragments for early lung cancer detection

DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study)

This study is testing a new blood test to see if it can help find lung cancer early in people who are at high risk, especially older smokers.

Quick facts

• Study type: Observational
• Enrollment: 2660 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Delfi Diagnostics Inc. (industry)
• Drugs / interventions: radiation
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT04825834 on ClinicalTrials.gov

What this trial studies

The DELFI-L101 study aims to train and test classifiers for the detection of lung cancer using the DELFI assay alongside other biomarker and clinical features. Participants will provide blood samples at enrollment, and their medical records will be reviewed 12 months later to assess outcomes. This observational study focuses on high-risk individuals, particularly current or former smokers aged 50 and older with a significant smoking history. The study seeks to improve early detection methods for lung cancer and potentially other related cancers.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older who are current or former smokers with a history of at least 20 pack-years.

Not a fit: Patients who do not meet the smoking history criteria or who have a confirmed lung cancer diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of lung cancer, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using biomarker assays for early cancer detection, suggesting that this approach may be viable.

Eligibility criteria

Inclusion Criteria:

All Participants:

1. Ability to understand and provide written informed consent
2. Age ≥ 50 years
3. Current or Former Smoker
4. ≥ 20 pack-years (pack years = number of packs per day X number of years smoked)

   Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below:
5. Prior thoracic imaging with computed tomography (CT) within 12 months of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)

   OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment (CT imaging for lung cancer screening for participants meeting inclusion criteria 6a and 6b; or CT imaging for lung cancer screening or diagnostic CT for participants meeting inclusion criteria 6c)

   AND
6. Meet one of the criteria below:

   1. No suspected or confirmed lung cancer diagnosis OR
   2. Suspected of lung cancer OR
   3. Confirmed, untreated lung cancer

   Inclusion Group 2: High Risk Patients that meet the following criteria:
7. Pathologic confirmed, invasive non-lung cancer diagnosis, originating from the esophagus (upper), colon or rectum, pancreas, stomach (including lower esophagus), head and neck, skin (excluding cutaneous basal cell and squamous cell carcinoma) kidney, or liver, with no prior systemic therapy, definitive therapy, radiation, or surgical resection.

OR Clinically confirmed invasive non-lung cancer diagnosis originating from the pancreas, kidney, or liver, based on imaging and clinical judgment with planned treatment and no prior systemic therapy, definitive therapy, radiation, or surgical resection.

OR Clinically (based on imaging and clinical judgment) or pathologically confirmed non-invasive or invasive bladder cancer with planned treatment and no prior systemic therapy, definitive therapy, radiation or surgical resection.

Exclusion Criteria:

All Participants:

1. Prior systemic therapy, definitive therapy, radiation, or surgical resection for cancer within one year prior to enrollment (with the exception of organ biopsies or surgery for non-melanoma skin cancer)
2. Any history of hematologic malignancies or myelodysplasia
3. Any history of organ tissue transplantation
4. Any history of blood product transfusion
5. Current pregnancy
6. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
7. Prior systemic therapy, definitive therapy, radiation, or surgical resection for the enrollment cancer diagnosis (with the exception of organ biopsies or surgery for non-melanoma skin cancer are not exclusionary)
8. Enrollment in any DELFI sponsored study

Where this trial is running

New York, New York and 1 other locations

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Peter Mazzone, MD, MPH — The Cleveland Clinic
• Study coordinator: Sonali Kotagiri

Conditions: Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Bladder Cancer, Kidney Cancer, Stomach Cancer, Colorectal Cancer, Pancreas Cancer